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临床试验/CTRI/2025/08/092311
CTRI/2025/08/092311
尚未招募
2 期

Comparative Study for Efficacy of Ultrasound Guided Pectoral Nerve Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Modified Radical Mastectomy.

School of Medical Sciences and Research Sharda Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月20日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
School of Medical Sciences and Research Sharda Hospital
入组人数
30
试验地点
1
主要终点
To assess and compare efficacy of post operative pain relief in both groups that is using NRS score.

概览

简要总结

This Randomized double Blinded Comparative Studt aims to Compare the Post Operative Analgesic Efficacy of Pectoral Nerve Block and Erector Spinae Plane Block in Patients who will be Undergoing Modified Radical Mastectomy under  General Anaesthesia.

A Total of 30 Patients of ASA Grade II AND III will be  Selected based on the Inclusion and Exclusion Criteria Aged between 18 to 60 years and will be Randomly Assigned into two Groups. Each group will have 15 Patients .

Group P : Patients will undergo Pectoral Nerve Block using Inj levobupivacaine 25 ml.

Group E : Patients will undergo Erector Spinae Plane Block using Inj Levobupivacaine 25 ML .

Primary Objective is to Assess and Compare the  Efficacy of Post Operative Pain Relief in both Using NRS Score.

Secondary Objectives Include time of Requirement for First Rescue Analgesic , Total  amount of Rescue Analgesic Consumed in Post Operative Period, Incidence of Nausea and Vomiting and any Complications like Hypotension and Hematoma.

The Patients will be Monitored Intraoperatively and for 24 hours in Post Operative Period.

The Study will be Conducted in Sharda Hospital, Greater Noida Over 18 Months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • ASA grade 2 AND 3
  • BMI less than 35
  • Patients who are able to understand and rate their Pain on NRS score.

排除标准

  • History of Allergy to Local Anaesthetic
  • Infection at Injection Site 3 Patients On Anti Coagulation therapy 4.Patients with Uncontrolled Hypertension and Diabetes Mellitus 5.Patients who have Renal , Liver or Cardiac Disease.

结局指标

主要结局

To assess and compare efficacy of post operative pain relief in both groups that is using NRS score.

时间窗: 24 hours post operative period

次要结局

  • 1.Time of requirement for first rescue analgesia in post operative period.(2.Total amount of rescue analgesic consumed in first 24hrs.)

研究者

发起方
School of Medical Sciences and Research Sharda Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anam Danish

School of Medical Sciences and Research Sharda University

研究点 (1)

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